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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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The US Food and Drug Administration (FDA) on Monday unveiled amended guidance on the liver warnings that must be contained in labels of some over-the-counter (OTC) drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours.

The guidance, which was initially issued in 2012, helps to clarify certain cases where manufacturers of internal analgesic, antipyretic and antirheumatic (IAAA) OTC drugs would be able to change liver warnings when the product’s directions for use result in a maximum daily dose of acetaminophen that is less than 4,000 mg for adults.

Background

Back in 2009, FDA issued a final rule changing some of the labeling requirements for OTC IAAA drugs to inform consumers about the risk of liver injury when using acetaminophen, which included popular products like Tylenol.

Under that rule, FDA laid out two specific liver warnings for OTC IAAA products containing acetaminophen, noting on products for adults only, “Severe liver damage may occur if you take more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: “for this product”]; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.”

The liver warning on the label for such drugs for children under 12 years of age also must include the same label as what’s used for adults and include a warning for children taking more than five doses in 24 hours.

New Guidance

FDA says that the optional statement, “for this product,” from the original warning is intended to help consumers understand that the maximum number of daily dosage units for a product might not reflect the maximum daily dose of acetaminophen.

However, the agency says that it understands that in certain circumstances, despite this optional statement, the wording might be interpreted as indicating that severe liver damage is associated with a total daily dose of acetaminophen that is less than 4,000 mg, which “is not the intent of the regulation.”

For example, FDA points to the maximum number of daily dosage units for an OTC acetaminophen-diphenhydramine combination drug, such as Tylenol PM, which "is limited by the product’s indication, and the total daily dose of acetaminophen for the product is significantly less than 4,000 mg."

New Label

Because of these circumstances, FDA says it “does not intend to object if a manufacturer chooses to use the following language” on the drug’s labeling:

Adults Only:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 4,000 mg of acetaminophen in 24 hours - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product.

Adults and children under 12 years of age:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if - adult takes more than 4,000 mg of acetaminophen in 24 hours - child takes more than 5 doses in 24 hours - taken with other drugs containing acetaminophen - adult has 3 or more alcoholic drinks every day while using this product.

But OTC IAAA products containing acetaminophen that are labeled only for children under 12 years of age must continue to include in their labeling the liver warning: